A Multicenter, Open-label, Phase II Umbrella Study to Evaluate the Efficacy and Safety of the Investigational Product in Participants With Advanced or Metastatic Pancreatic Cancer
2026年9月7日 更新者:Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
This is a multicenter, open-label, Phase II umbrella study conducted in participants with advanced or metastatic pancreatic cancer.
This study has set up different cohorts to evaluate the efficacy and safety of multiple investigational products in pancreatic cancer.
研究概览
研究类型
介入性
注册 (估计的)
30
阶段
- 阶段2
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form.
- Histologically or cytologically confirmed advanced or metastatic pancreatic cancer.
- Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 7 days before the first dose.
- Participants who have adequate bone marrow, liver, kidney, and coagulation function.
- Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.
- Participants must voluntarily join this study, sign the informed consent form (ICF), and be able to comply with the visits and related procedures specified in the protocol.
Exclusion Criteria:
- History or current metastases to central nervous system.
- Histologically or cytologically confirmed other pathological types or differentiation combined with other pathological types.
- Subjects with other malignant tumors within 3 years prior to the first dose.
- Presence of any cardiovascular and cerebrovascular disorders or risk factors.
- Presence of uncontrolled systemic disease.
- Presence of clinically symptomatic or uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- History of interstitial lung disease (ILD) or non-infectious pneumonitis.
- Presence within 3 months before the first dose of other moderate to severe lung disorders.
- Tumor invasion or compression of surrounding vital organs and major blood vessels.
- Active severe digestive system diseases.
- Unresolved toxicity from prior anti-tumor therapy.
- Serious infection within 4 weeks before the first dose.
- Presence of active HIV, hepatitis B or hepatitis C or co-infection with HBV and HCV.
- Known history of allogeneic organ transplant or hematopoietic stem cell transplant.
- History of allergy to any component of the study drug or severe hypersensitivity to other monoclonal antibodies.
- Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
- Participants who have received other investigational drug treatments within 4 weeks before the first dose.
- Pregnant or breastfeeding women.
- Known history of psychosis or drug abuse that prevents the participant from cooperating with the study.
- Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to higher medical risk and/or uncertainty in survival assessment, or may affect protocol compliance.
- Any condition that, in the investigator's opinion, interferes with the evaluation of the investigational product, participant safety, or interpretation of study results, or any other condition that the investigator deems unsuitable for participation in this study.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Cohort A: SKB571 monotherapy
|
q3w
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Objective response rate (ORR)
大体时间:Up to approximately 24 months.
|
ORR as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
|
Up to approximately 24 months.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-free survival (PFS)
大体时间:Up to approximately 24 months.
|
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
|
Up to approximately 24 months.
|
|
Duration of Response (DOR)
大体时间:Up to approximately 24 months.
|
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
|
Up to approximately 24 months.
|
|
Disease control rate (DCR)
大体时间:Up to approximately 24 months.
|
Assessed by the investigators as per RECIST v1.1
|
Up to approximately 24 months.
|
|
Overall Survival (OS)
大体时间:Up to approximately 24 months.
|
Time from start of treatment to death due to any reason.
|
Up to approximately 24 months.
|
|
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
大体时间:Up to approximately 24 months.
|
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (based on CTCAE v6.0), clinically significant abnormal laboratory test results.
|
Up to approximately 24 months.
|
|
Maximum Plasma Concentration (Cmax) of the investigational product
大体时间:Up to approximately 24 months.
|
Blood Samples will be collected to determine the Cmax of the investigational product in the plasma.
|
Up to approximately 24 months.
|
|
Minimum Plasma Concentration (Cmin) of the investigational product
大体时间:Up to approximately 24 months.
|
Blood Samples will be collected to determine the Cmin of the investigational product in the plasma.
|
Up to approximately 24 months.
|
|
Immunogenicity of the investigational product
大体时间:Up to approximately 24 months.
|
Incidence of anti-drug antibody (ADA) against the investigational product.
|
Up to approximately 24 months.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月31日
初级完成 (估计的)
2028年2月28日
研究完成 (估计的)
2028年5月31日
研究注册日期
首次提交
2026年9月2日
首先提交符合 QC 标准的
2026年9月7日
首次发布 (实际的)
2026年9月10日
研究记录更新
最后更新发布 (实际的)
2026年9月10日
上次提交的符合 QC 标准的更新
2026年9月7日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.